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Blog
MDR/IVDR Revision: Team-NB concerns over MD regulation shift
by
Gabriele Pincitore
|
21/04/2026
21/04/2026
|
Blog
,
Medical
The European medical device landscape is at a critical juncture. In its comprehensive position paper...
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Biocide Task Force: how to make your Regulatory Life easy
by
Gabriele Pincitore
|
14/04/2026
14/04/2026
|
Agro/Biocides
,
Blog
Biocide task forces are collaborative industry groups formed to bring together companies in the registration...
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March Regulatory Updates 2026
by
Gabriele Pincitore
|
08/04/2026
09/09/2026
|
Agro/Biocides
,
Blog
,
Chemical
Biocides: UK-EU SPS Alignment for PPPS & Biocides The new UK-EU SPS Agreement (targeted for...
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ICH Q3E: E&L risks with Material Variability and Supply Chain
by
Gabriele Pincitore
|
31/03/2026
31/03/2026
|
Blog
,
Pharma
ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
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USP Class VI: New Approach to Polymer Safety in Medical Devices
by
Gabriele Pincitore
|
24/03/2026
24/03/2026
|
Blog
,
Medical
For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...
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Novel Food in Ingredients and Food Supplements: Key Differences
by
Gabriele Pincitore
|
17/03/2026
17/03/2026
|
Blog
,
Food
Did you know that in the EU an ingredient can be classified as a Novel...
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Regulation EU 2026/405: New Detergents and Surfactants Compliance
by
Gabriele Pincitore
|
10/03/2026
10/03/2026
|
Blog
,
Chemical
Regulation (EU) 2026/405 is the new European Union regulation on detergents and surfactants, published in...
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February Regulatory Updates 2026
by
Gabriele Pincitore
|
03/03/2026
09/09/2026
|
Agro
,
Blog
,
Chemical
Biocides: BPC approves Ethanol use for disinfectants and hand sanitizers On February 24 in Helsinki,...
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Permitted Daily Exposure within EMA and ICH Framework
by
Gabriele Pincitore
|
24/02/2026
26/02/2026
|
Blog
,
Pharma
Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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EUDAMED is Now Mandatory: What has changed since May 2026
by
Gabriele Pincitore
|
17/02/2026
23/06/2026
|
Blog
,
Medical
The European Database on Medical Devices, a key element of the European Union’s regulatory framework...
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